Spontaneous reporting

We have discussed the vital role that spontaneous reporting plays in post-market/post-approval pharmacovigilance. Patient (consumer) and health care provider (HCP) reporting of potential adverse drug reactions and the subsequent medical adjudication and data-basing of this information into systems such as FDA’s FAERS and UMC’s Vigibase databases forms the backbone of how we continue to develop the safety profile and benefit: risk profile of approved drugs/biologics.

A unique part of the world we live in today is the ubiquity of social media. Facebook. Instagram. Twitter. We have so many tools at our fingertips for expressing our opinions to a large audience. And naturally, social media has become a platform for people to share their experiences with approved drugs/biologics.

Spend some time looking into the role that social media might play in serving as a platform for people to informally report on potential adverse drug reactions. See the following to get you started:

  1. MedSafety Week: https://www.who.int/medicines/news/2019/medicines-safety-week/en/
  2. “Using Facebook to Increase Spontaneous Reporting of Adverse Drug Reactions” See Week 11 “Assignments” tab for link to PDF

Share your thoughts on how you think social media might be used to help identify adverse drug reactions. What are the pros and cons of this type of approach? How might we get the social media ADRs transferred to databases like FAERS and VigiBase?

Sample Solution

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